BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183502522
• Version / Model: BR06-10920
• Catalog Number: BR06-10920
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-29
• Public Version: 1
• Public Version Date: 2023-04-06
• Public Version Status: New
• Public Device Record Key: 4226a6aa-6428-4562-8f75-ac8f7a1b07e1

Device Description

Myringotomy Blade Handle, for round stock blades, 4"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDZ	Handle, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65524	Tympanotomy knife handle	A hand-held manual surgical instrument designed to mount a tympanotomy knife blade (not included) intended for cutting or piercing the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery. The procedure is frequently followed by insertion of a drainage tube in cases of inflammation/infection of the middle ear (otherwise known as myringotomy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183502522	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]